Cleared Traditional

K861512 - EMDS

K861512 is the FDA 510(k) clearance for EMDS by Em Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code JJT) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K861512 · Em Diagnostic Systems, Inc. · Chemistry device
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May 1986
Decision
30d
Days
Class 1
Risk

K861512 is an FDA 510(k) clearance for the EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on May 23, 1986 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K861512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1986
Decision Date May 23, 1986
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJT Enzyme Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJT Enzyme Controls (assayed And Unassayed)

All 58
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K861512.
TITAN GEL REP CPK/LDH ISOENZYME CONTROL
K874141 · Helena Laboratories · Nov 1987
VIRON(TM)
K872646 · bioMerieux, Inc. · Sep 1987
DOCUMENT ENZYME LINEARITY TEST SETS
K861506 · Casco Standards · Jun 1986
ISOTRAK AMYLASE ISOENZYME CONTROL SET
K861329 · Behring Diagnostics, Inc. · Apr 1986
EMDS ENZYME VERIFIER, LEVELS I & II
K860764 · Em Diagnostic Systems, Inc. · Apr 1986
DELTA TROL I & II
K853373 · Electro-Nucleonics Laboratories, Inc. · Aug 1985